P103 Research governance audit on quality of documentation of hyperacute ATTEST 2 stroke trial, focusing on the informed consent process

BACKGROUND: The time constraints of hyperacute stroke trials can make documentation challenging. 70% of acutely ill patients lack capacity, thereby requiring proxy consent, and faultless documentation of informed consent in order to avoid ambiguity. This retrospective audit looked at quality of documentation, focusing on informed consent, in the ATTEST 2 trial. The ATTEST 2 trial is a multicentre randomised controlled trial comparing the efficacy of the experimental drug tenecteplase to alteplase (which is used in current practice) for IV thrombolysis to treat acute ischaemic stroke. METHODS: The consent forms and hospital notes of 13 participants of ATTEST 2 recruited into the trial at the Newcastle Royal Victoria Infirmary hospital from January-August 2018 were inspected. Criteria included documentation of all research visits (day 1, 2 and 5), inclusion and exclusion criteria being met, and presence of a dated, timed and signed consent form. Adherence to 38 criteria in patient records was assessed. Standards were based on GCP guidelines for documentation, especially section 4.8 on informed consent, and on the requirements for data recording set by the ATTEST 2 trial coordinators. This was stratified by date to compare documentation earlier and later on in the trial. RESULTS: Most criteria were adequately fulfilled. However, 22% of the criteria had a compliance of less than 60%. These included recording time of consent, the day 5 follow up visit, the attempt to reconsent if patient lacked capacity earlier, the voluntary nature of the trial, the risks and benefits, and that the patient had an opportunity to ask questions. The practices with compliance less than 60% decreased from 26% from January-April 2018 to 21% from May-August 2018. CONCLUSIONS: The level of documentation varied between patient records, and though most criteria were met, some did not meet ideal standards. This seemed to improve over the course of the ATTEST 2 trial. This audit findings were presented to the team involved. Inconsistency of documentation was discussed and documentation standards were reviewed. A re-audit should be carried out and it should be investigated whether the quality of documentation continued to improve over time.